It was reported that after wearing the pod on the abdomen between 36 and 48 hours, the site was irritated, painful and oozing with contact dermatitis.The patient developed an allergic reaction to the adhesive which caused a rash breakout in every part of the body.The patient, visited the general practitioner (gp) who prescribed hydrocortisone as treatment.
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According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the skin irritation and allergic reaction to the pod's adhesive.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneously reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6 per iso11135 and eo residual levels in compliance with iso10993.Each lot is confirmed to meet requirements for non-pyrogenicity per iso10993 and sterility per iso11135 prior to release.
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